A Study Comparing Remimazolam Tosilate and Propofol for Intravenous General Anaesthesia in Operations

Jiangsu HengRui Medicine Co., Ltd.144 enrolled

Overview

The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as an intravenous general anaesthetic drug in operations and to determine its efficacy and safety profile comparing to propofol.

This is an multi-center，double-blinded，parallel and control study using Remimazolam or propofol for anesthesia in operations.Subjects are randomized to different treatment groups (including 3 for Remimazolam Tosilate and 1 for propofol) and anaesthetics are pumped contimuously into bodies.Analgesics and muscle relaxants are permitted during operations.Efficacy，safety and pharmacokinetic/pharmacodynamic profiles of Remimazolam Tosilate are to be evaluated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

144

Conditions

General Anesthesia

Interventions

Remimazolam TosilateDRUG

IV pumping for anesthesia

PropofolDRUG

IV bolus for anesthesia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * subjects aged 18-60 years； * intending to have non-emergency operations； * ASA( American Society of Anesthesiologists) I or II； * 18 kg/m²\<BMI(Body Mass Index)\<30 kg/m². Exclusion Criteria: * people with contraindications to general anaesthesia; * one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.); * history of recent use of narcotics,analgesics,anaesthetics and benzodiazepine hypnotics; * history of severe cardiovascular disease; * uncontrolled blood glucose level; * cerebral disease or mental disorder; * allergic to drugs used in the study; * pregnant women or those in lactation period.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

successful anaesthesia rate as measured by the proportion of subjects who experienced succesful anesthesia during operations

Time frame: an average of 3 hours (immediately after opaerations)

Secondary Outcomes

bispectral index(BIS) during anaesthesia as measured by bispectral index machine

Time frame: every 5 minutes

recovery time as measured by time

Time frame: an average of 3 hours (after cessation of anesthetics pumping)

induction time as measured by time

Time frame: 1-10 minutes (from the begining of anesthetics)

Data from ClinicalTrials.gov

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